| 溶菌酶的处方设计前稳定性研究 |
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| 引用本文： | 周闺臣,刘青锋,鲁莹,钟延强.溶菌酶的处方设计前稳定性研究[J].药学实践杂志,2010,28(1):11-13,44. |
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| 作者姓名： | 周闺臣 刘青锋 鲁莹 钟延强 |
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| 作者单位： | 第二军医大学药学院药剂学教研室,上海,200433 |
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| 摘 要： | 目的考察pH值、温度、保护剂、有机溶剂对溶菌酶物理稳定性和生物活性的影响，为其缓释注射剂的处方学研究提供依据。方法以HPLC法测定溶液中溶菌酶的含量，以比浊法测定溶菌酶的生物活性。结果在pH4．0、pH10．0条件下溶菌酶的物理稳定性较好，pH4．0条件下溶菌酶可保持较高的生物活性，pH1．0的条件会完全破坏溶菌酶的溶菌活性；低温条件有利于保持溶菌酶的物理稳定性和生物活性；甘露醇对溶菌酶的稳定性具有先增强后减弱的作用；有机溶剂会严重破坏溶菌酶的物理稳定性，但仍保留着一部分溶菌活性。结论pH值、温度、保护剂、有机溶剂对溶菌酶的物理稳定性和生物活性具有明显影响。
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| 关 键 词： | 溶菌酶 处方设计前T作 稳定性 |
| 收稿时间： | 2009/10/10 0:00:00 |
| 修稿时间： | 2009/11/30 0:00:00 |
Stability studies of lysozyme for preformulation |
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| ZHOU Gui-chen,LIU Qing-feng,LU Ying and ZHONG Yan-qiang.Stability studies of lysozyme for preformulation[J].The Journal of Pharmaceutical Practice,2010,28(1):11-13,44. |
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| Authors: | ZHOU Gui-chen LIU Qing-feng LU Ying and ZHONG Yan-qiang |
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| Institution: | ZHOU Gui-chen,LIU Qing-feng,LU Ying,ZHONG Yan-qiang(Department of Pharmaceutical Science,School of Pharmacy,Second Military Medical University,Shanghai 200433,China) |
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| Abstract: | Objective To investigate the influence of pH value,temperature,protectant and organic solvent on the physical stability and biological activity of lysozyme.Methods The concentration of lysozyme was determined by HPLC and the biological activity of lysozyme was tested by turbidimetric method.Results Lysozyme was physically stable at pH4.0 and pH10.0.The biological activity of lysozyme was kept well at pH4.0 while it was totally destroyed at pH1.0.Low temperature tended to protect lysozyme from damage.Mannito... |
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| Keywords: | lysozyme preformulation stability |
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